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Medico-economic Comparison of Postpartum Hemorrhage Management Using the Bakri Balloon and Standard Care (Bakri)

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ClinicalTrials.gov Identifier: NCT01980173
Recruitment Status : Recruiting
First Posted : November 8, 2013
Last Update Posted : September 30, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Brief Summary:

This study concerns women diagnosed with postpartum hemorrhage and requiring sulprostone therapy. Included patients are randomized to two arms: the "Sulprostone + Bakri balloon" arm versus the "Sulprostone alone" arm.

The main objective of this study is to compare the efficiency of a care strategy including the Bakri balloon to that of routine care without the Bakri balloon via a cost-consequence study juxtaposing costs and the necessity of invasive procedures (arterial embolization, ligation of arteries, hysterectomy, intrauterine sutures) for controlling postpartum hemorrhage.


Condition or disease Intervention/treatment
Postpartum Hemorrhage Procedure: Routine care Device: Bakri balloon

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Medico-economic Comparison of Postpartum Hemorrhage Management Using the Bakri Balloon and Standard Care
Study Start Date : September 2014
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: With Bakri balloon

Patients randomized to this arm will be treated using the Bakri balloon.

Intervention: Bakri balloon

Device: Bakri balloon
Following diagnosis with post-partum hemorrhage, an initial 30 minute phase corresponding to current recommendations, an injection of sulprostone, a demonstrated inefficacy of sulprostone 20 minutes after the injection and finally randomization, patients in this arm will be treated with the immediate placement of a Bakri balloon, followed by routine care if necessary.
Active Comparator: Without Bakri balloon

Patients randomized to this arm will receive routine care not including the Bakri Balloon.

Intervention: Routine Care

Procedure: Routine care
Following diagnosis with post-partum hemorrhage, an initial 30 minute phase corresponding to current recommendations, an injection of sulprostone, a demonstrated inefficacy of sulprostone 20 minutes after the injection and finally randomization, patients in this arm of the study will continue to have routine care.



Primary Outcome Measures :
  1. The % of patients requiring invasive measures for postpartum hemorrhage control. [ Time Frame: Hospital stay (expected max of 15 days). ]
  2. The total cost (€) associated with the postpartum hemorrhage management strategy. [ Time Frame: Hospital stay (expected max of 15 days). ]

Secondary Outcome Measures :
  1. The delay required to stop bleeding post-delivery (min) [ Time Frame: post-partum (expected maximum of a few hours) ]
  2. The delay required to stop bleeding post-diagnosis (min) [ Time Frame: post-partum (expected maximum of a few hours) ]
  3. The percentage of patients still bleeding 30 minutes after sulprostone injection [ Time Frame: 30 minutes after sulprostone injection (day 0) ]
  4. Blood loss (ml) 30 minutes after diagnosis [ Time Frame: 30 minutes after diagnosis (day 0) ]
  5. Blood loss (ml) 1 hour after diagnosis [ Time Frame: 1 hour after diagnosis (day 0) ]
  6. Blood loss (ml) 2 hours after diagnosis [ Time Frame: 2 hours after diagnosis (day 0) ]
  7. Blood loss (ml) 24 hours after diagnosis [ Time Frame: 24 hours after diagnosis (day 1) ]
  8. Blood pressure [ Time Frame: Upon diagnosis (day 0) ]
  9. Blood pressure [ Time Frame: 30 minutes after diagnosis (day 0) ]
  10. Blood pressure [ Time Frame: 120 minutes after diagnosis (day 0) ]
  11. Blood pressure [ Time Frame: 24 hours after diagnosis (day 1) ]
  12. Blood pressure [ Time Frame: upon sulprostone injection (day 0) ]
  13. Blood pressure [ Time Frame: when placing the Bakri balloon (day 0) ]
  14. Blood pressure [ Time Frame: when performing invasive techniques (expected day 0 or 1) ]
  15. Heart rate [ Time Frame: Upon diagnosis (day 0) ]
  16. Heart rate [ Time Frame: 30 minutes after diagnosis (day 0) ]
  17. Heart rate [ Time Frame: 120 minutes after diagnosis (day 0) ]
  18. Heart rate [ Time Frame: 24 hours after diagnosis (day 1) ]
  19. Heart rate [ Time Frame: upon sulprostone injection (day 0) ]
  20. Heart rate [ Time Frame: when placing the Bakri balloon (day 0) ]
  21. Heart rate [ Time Frame: when performing invasive techniques (expected day 0 or 1) ]
  22. The % of patients requiring blood transfusion. [ Time Frame: Hospital stay (expected max of 15 days). ]
  23. The % of patients requiring intravenous iron. [ Time Frame: Hospital stay (expected max of 15 days). ]
  24. The quantity of packed red cells, platelet concentrate and fresh frozen plasma consumed [ Time Frame: Hospital stay (expected max of 15 days). ]
  25. Fibrinogen (g / l) [ Time Frame: Upon diagnosis (day 0) ]
  26. Fibrinogen (g / l) [ Time Frame: Day 1 ]
  27. Fibrinogen (g / l) [ Time Frame: Day 3 ]
  28. Hematocrit (%) [ Time Frame: Upon diagnosis (day 0) ]
  29. Hematocrit (%) [ Time Frame: Day 1 ]
  30. Hematocrit (%) [ Time Frame: Day 3 ]
  31. Hematocrit (%) [ Time Frame: the month preceding delivery ]
  32. Hemoglobin (g/dl) [ Time Frame: Upon diagnosis (day 0) ]
  33. Hemoglobin (g/dl) [ Time Frame: Day 1 ]
  34. Hemoglobin (g/dl) [ Time Frame: Day 3 ]
  35. Hemoglobin (g/dl) [ Time Frame: the month preceding delivery ]
  36. Prothrombin (%) [ Time Frame: the month preceding delivery ]
  37. Prothrombin (%) [ Time Frame: Upon diagnosis (day 0) ]
  38. Prothrombin (%) [ Time Frame: Day 1 ]
  39. Prothrombin (%) [ Time Frame: Day 3 ]
  40. Activated partial thromboplastin time (s) [ Time Frame: the month preceding delivery ]
  41. Activated partial thromboplastin time (s) [ Time Frame: Upon diagnosis (day 0) ]
  42. Activated partial thromboplastin time (s) [ Time Frame: Day 1 ]
  43. Activated partial thromboplastin time (s) [ Time Frame: Day 2 ]
  44. Length of hospital stay (days) [ Time Frame: Expected max of 15 days ]
  45. Length of ICU stay [ Time Frame: expected max of 15 days ]
  46. Antimullerian hormone level [ Time Frame: Upon diagnosis (Day 0) ]
  47. Antimullerian hormone level [ Time Frame: 2 months after restart of menses ]
  48. Amenorrhea at 3 months? yes/no [ Time Frame: 3 months ]
    (Excluding breastfeeding women)

  49. The presence of adhesions detected at hysteroscopy [ Time Frame: 3 months after delivery if menses have restarted, or 2 months after the restart of menses (maximum of 1 year after inclusion) ]
  50. pain will be assessed in both arms via a visual analog scale, duration, location, and use of analgesics [ Time Frame: Day 1 ]
  51. pain will be assessed in both arms via a visual analog scale, duration, location, and use of analgesics [ Time Frame: Day 3 ]
  52. temperature (°C) [ Time Frame: Daily while in hospital (expected maximum of 15 days) ]
  53. FSFI questionnaire (Female Sexual Function Index) [ Time Frame: 6 months ]
  54. Doppler ultrasound: intrauterine pressure [ Time Frame: when placing the Bakri balloon; day 0 ]
  55. Doppler ultrasound: thickness of the uterine wall [ Time Frame: when placing the Bakri balloon; day 0 ]
  56. Doppler ultrasound: inversed diastolic flow [ Time Frame: when placing the Bakri balloon; day 0 ]
  57. Doppler ultrasound: intraluminal pressure [ Time Frame: when placing the Bakri balloon; day 0 ]
  58. Doppler ultrasound: uterine artery perfusion pressure [ Time Frame: when placing the Bakri balloon; day 0 ]
  59. Doppler ultrasound: uterine artery pulsatility index [ Time Frame: when placing the Bakri balloon; day 0 ]
  60. IES-R scale (symptoms of post-traumatic stress) [ Time Frame: 6 months ]
  61. Vascular filling required? yes/no [ Time Frame: Day 0 ]
  62. If vascular filling is required, volume and type of solution used. [ Time Frame: Day 0 ]
  63. Were amines required? yes/no [ Time Frame: Day 0 ]

Other Outcome Measures:
  1. Prophylactic antibiotherapy? yes/no [ Time Frame: Day 0 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient, her person-of-trust, must have given his/her consent and signed the consent form / inclusion decision made by the investigator when a person-of-trust is absent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient is able to fluently read and speak French
  • Blood loss > 500ml and sulprostone treatment is insufficient at 20 minutes
  • Duration of pregnancy > 32 weeks of amenorrhea
  • Uterine atony

Exclusion Criteria:

  • The patient is participating in another study except for the followin studies: ElastoMAP, ElastoDéclench, Papillo PMA, GrossPath, LXRs, DGPostPartum
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient cannot read French
  • The patient was transferred to another center not among the centers participating in this study
  • The patient has a contraindication for a treatment used in this study (Sulprostone), or an incompatible treatment combination
  • The patient has a contraindication for third level techniques
  • The patient has at least one of the following conditions: chorioamnionitis, cervical cancer, uterine rupture, anatomical abnormality preventing the introduction of the device, purulent infection of the vagina, cervix or uterus.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01980173


Contacts
Contact: Vincent Letouzey, MD +33.(0)4.66.68.37.99 vincent.letouzey@chu-nimes.fr
Contact: Carey Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
CHU d'Angers - Hôtel-Dieu Not yet recruiting
Angers, France, 49933
Sub-Investigator: Guillaume Legendre, MD         
APHP - Hôpital Antoine Beclere Recruiting
Clamart Cedex, France, 92141
Sub-Investigator: Alexandra Benachi, MD, PhD         
APHP - Centre Hospitalier Universitaire de Bicêtre Recruiting
Le Kremlin Bicêtre Cedex, France, 94275
Sub-Investigator: Hervé Fernandez, MD, PhD         
Sub-Investigator: Marie Houllier, MD         
APHM - Hôpital Nord Recruiting
Marseille Cedex 20, France, 13915
Sub-Investigator: Florence Bretelle, MD, PhD         
CHRU de Montpellier - Hôpital Arnaud de Villeneuve Recruiting
Montpellier, France, 34295
Sub-Investigator: Emmanuelle Vintejoux, MD         
Sub-Investigator: Mélanie Cayrac, MD         
CHRU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 9, France, 30029
Principal Investigator: Vincent Letouzey, MD         
Sub-Investigator: Eve Mousty, MD         
Sub-Investigator: Pierre Marès, MD, PhD         
Sub-Investigator: Florent Masia, MD         
Sub-Investigator: Renaud de Tayrac, MD, PhD         
CHU de Saint Etienne - Hôpital Nord Recruiting
Saint-Priest en Jarez, France, 42270
Sub-Investigator: Céline Chauleur, MD, PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Vincent Letouzey, MD Centre Hospitalier Universitaire de Nîmes

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01980173     History of Changes
Other Study ID Numbers: LOCAL/2012/VL-04
2013-A00914-41 ( Other Identifier: RCB number )
First Posted: November 8, 2013    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: September 2016

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Bakri balloon

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage